Transcript
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Expert Perspectives: Conversations on CABENUVA
Uncovering Patient Challenges With Taking Daily HIV Treatment
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Dr Bettacchi: Hello, my name is Dr Christopher Bettacchi. I am an infectious disease specialist in Dallas, Texas. Please join me for a discussion on Unmet Needs of Patients on Daily HIV Treatment.
Before we begin, let us review Important Safety Information for CABENUVA.
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Speaker has been compensated by ViiV Healthcare
Christopher Bettacchi, MD
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VO: CABENUVA is for virologically suppressed adults and adolescents with HIV-1 who meet certain requirements. See full indication on screen.
It is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine and in patients receiving the medications listed here.
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
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INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
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Dr Bettacchi: For over a decade, I have been part of a team of infectious disease specialists that treat a large and diverse population of people living with HIV. In our practice, which includes about 1000 people living with HIV, I participate in an LGBTQ+ health and wellness clinic, which is a primary care–focused resource center for our patients within that community.
Dr Bettacchi: The last few years of the COVID-19 pandemic have truly brought to light the power of conversations with my patients. Like many other clinics across the country, we transitioned briefly to primarily telehealth visits in 2020, and it actually was a great experience for our practice in terms of being able to spend more time speaking with patients.
It didn't take very long in these conversations to learn that a patient, who otherwise would have come in and quickly said, “I'm doing fine,” actually may be dealing with challenges taking their oral antiretroviral therapy. Although we have transitioned to a hybrid mix of in-person and telehealth clinic visits, that experience in 2020 uncovered my passion for these types of discussions with my patients. This approach helps to reveal their unmet needs with taking daily oral HIV therapy.
Dr Bettacchi: My approach to initiating conversations is through patient education, and that starts with us as providers. I start by discussing what is going on in the HIV treatment landscape. I think it is incumbent upon anyone who cares for patients with HIV to share this knowledge with patients. I stay abreast of the changing treatment landscape. This allows me to share an alternative therapy with a different method of HIV drug delivery, such as CABENUVA. Usually, this information sparks an interest in my patients, and they say, “tell me more.” From there, I probe to see if they have challenges with taking their current regimen.
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Uncovering patients’ unmet needs in HIV treatment
- Patient education
- HIV treatment landscape
- Latest treatment options
- Taking daily oral HIV therapy
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Dr Bettacchi: On the other hand, some patients start the conversation by asking about CABENUVA. In those instances, I share the clinical data that support CABENUVA’s efficacy, safety, and tolerability.
Dr Bettacchi: When I discuss with my patients the challenges that they experience with taking daily oral therapy, there are several topics that are often mentioned. First is that they worry about others unintentionally discovering their HIV status, and that comes in different varieties. Whereas it was once about being seen in a pharmacy picking up HIV medication, today unintentional discovery of their HIV status means so much more when viewed through the lens of social media, and my patients have expressed this concern. My patients also worry over having to take a pill every day and possibly forgetting to take their HIV medication. Another common challenge is that taking oral HIV medication every day is an uncomfortable reminder of their HIV status and the circumstances around their initial diagnosis. As diverse as our patient population is, I find that challenges around use of daily oral therapy cut across all patient demographics.
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What are the challenges patient face with taking daily oral therapy?
- Unintentionally having their HIV status discovered
- Forgetting to take their HIV medication
- Uncomfortable reminder of their HIV status
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Dr Bettacchi: We need to consider the different challenges people living with HIV face, which may be constant concerns in their lives, even if they are virologically suppressed.
Most recently, the phase 3b trial of CABENUVA, the SOLAR study, compared the efficacy and safety of switching to every-2-month CABENUVA versus remaining on BIKTARVY through 12 months in patients who were virologically suppressed on BIKTARVY for at least 6 months prior to the study. In addition, the SOLAR study had a baseline survey to address whether patients entering the trial experienced challenges with taking their daily oral therapy as an exploratory endpoint.
For a detailed discussion of SOLAR, please watch the video titled, “SOLAR: a head-to-head switch study of CABENUVA vs BIKTARVY,” which is hosted by Dr Moti Ramgopal, an investigator of SOLAR.
Dr Bettacchi: I think it is important to grasp how much these challenges can impact patients’ lives, whether it’s someone who is traveling and worries about inadvertently disclosing their HIV status because of their medication or that they might forget to take their daily oral therapy.
One must also be aware that patients may hesitate to voice these concerns because they don’t want to burden their healthcare providers. I have been treating several of my patients for many years, and some have a hard time admitting to challenges that they have with adherence because they don’t want to “let us down.” These patients often feel guilty about speaking of their challenges with daily oral therapy because they know it used to be a lot harder than it is now.
Dr Bettacchi: I think the best way to help patients express the challenges they live with in their HIV treatment is to initiate a comfortable conversation with the patients, which starts with us as their providers. If that can be accomplished, we can begin to bring down the barriers around awareness of unmet patient needs. I find it helps to ask specific questions to see if they relate to certain challenges, which can then be identified and discussed further. For example, I might ask my patients if they hide their medication from those around them, if it is difficult to remember to take their oral treatment every day, or if they feel that their HIV medication is an uncomfortable reminder of their status.
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Start a conversation with a patient who may be struggling with taking daily oral therapy
- Do you hide your medication from those around you?
- Is it difficult to remember to take your oral treatment every day?
- Do you feel that your HIV medication is an uncomfortable reminder of your HIV status?
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Dr Bettacchi: To summarize our conversation today, some patients living with HIV may experience challenges regarding the use of daily oral antiretroviral therapy. As their providers, it’s important to meet our patients where they are and help them both recognize and overcome these challenges together.
On behalf of ViiV Healthcare, I would like to thank you for taking the time to learn about patient unmet needs and some strategies to uncover them.
Continue watching for additional Important Safety Information.
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Continue watching for additional Important Safety Information.
VO:
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and during postmarketing experience with rilpivirine-containing regimens where reactions include cases of drug reaction with eosinophilia and systemic symptoms. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Oral lead-in may be administered prior to administration of CABENUVA to help identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions:
In clinical trials, serious post-injection reactions, such as those shown here, were reported in less than 1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
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VO: It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity:
Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders:
Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive symptoms.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Post-Injection Reactions (continued):
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
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VO:
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA:
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to loss of virologic response and development of resistance. It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
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VO:
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here. The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine. It is not recommended to coadminister CABENUVA with other antiretrovirals. Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
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IMPORTANT SAFETY INFORMATION (continued)
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
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VO:
USE IN SPECIFIC POPULATIONS
Assess the potential risks of using CABENUVA during conception, pregnancy, and while breastfeeding
Please click the link to view the Prescribing Information for CABENUVA.
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IMPORTANT SAFETY INFORMATION (continued)
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
Please click the link to view the Prescribing Information for CABENUVA.
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Dr. Bettacchi: Are you interested in hearing more? Please watch the other videos in the series, “Expert Perspectives: Conversations on CABENUVA”.
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Expert Perspectives: Conversations on CABENUVA
Interested in hearing from more experts?
Check out our other videos in the “Expert Perspectives: Conversations on CABENUVA” series!
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